Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Radboud University Medical Center20 enrolled

Overview

The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Membranous Nephropathy

Interventions

tetracosactide hexacetaatDRUG

Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy-proven idiopathic membranous nephropathy. * Nephrotic syndrome: proteinuria \> 3.5 g/day and serum albumine \< 30 g/l * Normal or mildly impaired renal function (eGFR \> 60 ml/min, MDRD formula) * High risk for renal failure: beta-2-microglobulin excretion \> 500 ng/min * Relative contra-indication for cyclophosphamide treatment: * fertility and wish for (future) family expanding * high age ( \> 60 years) * former cyclophosphamide treatment * intolerance to cyclophosphamide Exclusion Criteria: * Clinical,biochemical or histological signs of any underlying systemic disease * Any infectious disease (including latent tuberculosis and/or latent amoebiasis) * Active gastric or duodenal ulcers * Pregnancy, lactation, inadequate contraceptives * Clinical signs of renal vein thrombosis * Asthma and /or any allergic conditions or hypersensitivity reactions * Allergic reaction to synthetic ACTH in the past

Locations (1)

Radboud University

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.

Time frame: 9 months

Secondary Outcomes

Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment

Time frame: 9 and 24 months

Data from ClinicalTrials.gov

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